ISO INTERNATIONAL STANDARD 10555-3 Second edition 2013-06-15 Intravascular catheters-Sterile and single-usecatheters Part 3: Centralvenouscatheters Catheters intravasculaires-Catheters steriles et non reutilisables- Partie3:Cathéterscentrauxveineux Reference number ISO 10555-3:2013(E) ISo (ISO2013 IS010555-3:2013(E) COPYRIGHTPROTECTEDDOCUMENT ISO2013 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either IsO at the address below or Iso's member body in the country of the requester. ISO copyright office Case postale 56.CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail [email protected] Web www.iso.org Published in Switzerland ii @ IS0 2013 - All rights reserved IS010555-3:2013(E) Contents Page Foreword iv 1 Scope 1 2 Normativereferences 1 3 Termsanddefinitions 1 4 Requirements 1 4.1 General. 1 4.2 Distance markings. 1 4.3 Lumen markings. 1 4.4 Peaktensileforce. 2 4.5 Information to be supplied by the manufacturer 2 Bibliography 3 ili @ ISO 2013 All rights reserved IS010555-3:2013(E) Foreword Iso (the International Organization for Standardization) is a worldwide federation ofnational standards bodies (Iso member bodies). The work of preparing International Standards is normally carried out through Iso technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with Iso, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnicalstandardization International Standards are drafted in accordance with the rules given in the ISo/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies castinga vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. IsO shall not be held responsible for identifying any or all such patent rights. ISO 10555-3 was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal productsand intravascularcatheters. This second edition cancels and replaces the firstedition (IS0 10555-3:1996), which has been technically revised.It also incorporates the Technical Corrigendum IS0 10555-3:1996/Cor 1:2002. ISo 10555 consists of the following parts, under the general title Intravascular catheters-Sterile and single-use catheters: Part 1: General requirements Part3: Central venous catheters Part 4: Balloon dilatation catheters Part5:Over-needleperipheralcatheters Thefollowing partis under preparation: Part 6:Subcutaneous implanted ports The following part has been withdrawn and the content has been included in ISO 10555-1: Part 2:Angiographic catheters Attention is drawn to Iso 11070, which specifies requirements for accessory devices for use with intravascular catheters. iv @ IS0 2013 - All rights reserved INTERNATIONALSTANDARD IS010555-3:2013(E) IntravascularcathetersSterileandsingle-usecatheters Part 3: Centralvenouscatheters 1 Scope This part of Iso 10555 specifies requirements for central venous catheters supplied in the sterile condition,and intended for single use. Normative references 2 The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced docum